[00:00:00] Speaker 00: All right. [00:00:01] Speaker 00: The next case before the court is 192404, James Cornelius versus HHS. [00:00:09] Speaker 00: Mr. Downing, you've reserved three minutes for rebuttal. [00:00:11] Speaker 00: Are you prepared to begin? [00:00:12] Speaker 01: I am, Your Honor. [00:00:15] Speaker 01: Okay. [00:00:16] Speaker 01: Proceed. [00:00:19] Speaker 01: Thank you. [00:00:20] Speaker 01: Good morning, Your Honors. [00:00:22] Speaker 01: Again, my name is Andrew Downing. [00:00:23] Speaker 01: I represent the appellant in this matter, Stacey James Cornelius. [00:00:28] Speaker 01: And I'm here on yet another appeal from the vaccine program where the special masters petitioner believes are misapplying the reasonable basis standard for the award of attorney's fees and expenses. [00:00:44] Speaker 01: And I think this appeal, Your Honors, boils down to what is required to support a finding of reasonable basis. [00:00:53] Speaker 01: I can start with what is not required. [00:00:58] Speaker 01: It is not required that a treating doctor opine that injuries are vaccine-related, nor is it required for reasonable basis to exist to have an expert opine that would somehow satisfy that reasonable basis standard. [00:01:17] Speaker 01: Instead, a petitioner need only demonstrate that a claim is feasible, not that there is even a likelihood of success, just feasible. [00:01:29] Speaker 01: So what is needed to establish reasonable basis? [00:01:33] Speaker 00: Why don't you focus on Cottingham? [00:01:35] Speaker 00: Because I think that's probably the critical question here is the extent to which Cottingham would control this case, the extent to which there's any distinctions from Cottingham, the extent to which you think there are additional factors. [00:01:49] Speaker 00: I mean, I really think that given how recent it is, that's where we ought to go. [00:01:54] Speaker 01: Well, I think, Your Honor, you're probably right on that. [00:01:58] Speaker 01: And Judge Raina wrote Cottingham. [00:02:02] Speaker 01: So I was glad to see, Your Honor, on this panel. [00:02:06] Speaker 01: But I think there are a lot of similarities here. [00:02:12] Speaker 01: And that is buttressed by the fact that the FLE asked to have this particular case stayed while we waited on the result in Cottingham. [00:02:22] Speaker 01: And I think what Cottingham says, [00:02:24] Speaker 01: is in order to establish reasonable basis, what you need when you plead a petition, you need a covered vaccine, you need medical records that reflect the injury being claimed, and then you need some basis, some feasible basis for why there would be a connection between the two. [00:02:54] Speaker 01: me as petitioner's counsel or a petitioner feel as though this injury is vaccine related. [00:03:03] Speaker 01: What objective evidence would there be to demonstrate that? [00:03:07] Speaker 00: And you can prove that. [00:03:09] Speaker 00: I think the feeling part is problematic because that implies subjective. [00:03:12] Speaker 00: But what you're saying is what is it that would have objectively justified that? [00:03:21] Speaker 01: Your Honor, I lost you there at the tail end of what you were saying. [00:03:25] Speaker 00: I said that what you really need to focus on is what in the record would objectively support your bringing a claim. [00:03:34] Speaker 01: That's right, Your Honor. [00:03:36] Speaker 01: I mean, I was sort of speaking tongue-in-cheek as far as that feeling. [00:03:40] Speaker 01: I think you're right. [00:03:40] Speaker 01: That word would imply a subjective type of evidence, and that is not the standard. [00:03:47] Speaker 01: I agree with you that you have to look at any of these vaccine cases from the record that the special master had, and what objective evidence would there be to indicate that this may [00:04:03] Speaker 01: be a vaccine injury. [00:04:06] Speaker 01: Here, Your Honor, I mean, there's no dispute that the petitioner received a covered vaccine. [00:04:14] Speaker 01: There's no dispute that the petitioner's symptoms lasted beyond six months, which in and of itself sort of dispels any mistaken belief that this young man simply had mono. [00:04:26] Speaker 01: But evidence in the form of medical records demonstrating the injury claimed. [00:04:31] Speaker 01: The injury here that's claimed in the petition was POTS, an autonomic nervous system dysfunction. [00:04:38] Speaker 01: That injury is well documented in this child's medical chart. [00:04:42] Speaker 01: The special master referenced it multiple times in her decision. [00:04:47] Speaker 01: Following the administration of Gardasil, this child began to experience the symptoms claimed. [00:04:53] Speaker 01: Again, the special master recognized that because she indicated in her opinion [00:04:58] Speaker 01: that very fact when she said at best what petitioner could show was that all of the symptoms manifested after Gardasil. [00:05:07] Speaker 01: Well, that's exactly right. [00:05:08] Speaker 01: They did. [00:05:08] Speaker 00: The medical chart shows... Isn't it more important that the symptoms actually be consistent with what Gardasil says the symptoms could follow? [00:05:23] Speaker 00: I mean, that the Gardasil, its own package insert says the symptoms could follow and they include syncope and other things that are similar to the symptoms that you see with POTS, right? [00:05:38] Speaker 01: That's exactly right, Your Honor. [00:05:40] Speaker 01: I mean, and that's exactly what happened in Cottingham. [00:05:44] Speaker 01: That's what happened here. [00:05:45] Speaker 01: You know, we cited for the Special Master the product monograph. [00:05:50] Speaker 01: But this case is even stronger than Cottingham. [00:05:53] Speaker 01: Here, after the symptoms were present for an extended period of time, the diagnosis of POTS had been made already, and after clinical examination, the treating physician contemplated filing a VAERS form, a Vaccine Adverse Event Reporting System form, indicating that at a minimum, [00:06:17] Speaker 01: I mean, we don't know what was going on in this doctor's mind, but he noted it in the objective plan in the medical chart, question mark, theirs. [00:06:28] Speaker 01: So at a minimum, this physician is contemplating reporting a vaccine adverse event to the CDC. [00:06:38] Speaker 01: That is far beyond the evidence that was present in Cottingham. [00:06:42] Speaker 01: and it may very well be the most important piece of evidence here. [00:06:46] Speaker 01: In addition to the product monograph and, you know, counsel for the government pointed out that we didn't file the medical literature below. [00:06:55] Speaker 01: That's true, I don't typically file a bunch of medical literature that's not sponsored by an expert, but the reason I cite to it and cite it in the petition is so that the special master knows the due diligence that counsel has gone to and these medical journal articles are titled things like [00:07:12] Speaker 01: postural orthostatic tachycardia syndrome following HPV vaccination. [00:07:17] Speaker 01: So I referenced that. [00:07:21] Speaker 00: I'm sorry. [00:07:21] Speaker 00: Go ahead. [00:07:22] Speaker 00: Was that Judge Chen or? [00:07:23] Speaker 03: Yeah, it was me. [00:07:24] Speaker 03: But you go ahead, Judge O'Malley. [00:07:26] Speaker 00: Well, again, I'm a little confused by your choice of words. [00:07:33] Speaker 00: You said you offered it to show all the efforts that you made. [00:07:41] Speaker 00: Simmons says that counsel's conduct isn't relevant, and we also have the issue that there's a difference between what constitutes bad faith, which nobody's questioning here, and what constitutes objective evidence. [00:07:56] Speaker 00: So are you saying that you don't think the articles constitute objective evidence? [00:08:03] Speaker 01: No, no, no, Your Honor. [00:08:04] Speaker 01: And what I meant by that was I do think that journal articles constitute objective evidence. [00:08:11] Speaker 01: And I don't want to spend a lot of time on the articles because, you know, I didn't submit them. [00:08:16] Speaker 01: I didn't try and make Special Master Sanders read 17, you know, medical journal articles. [00:08:23] Speaker 01: The reason that they are referenced is by title. [00:08:27] Speaker 01: The effort was to demonstrate to the special master that medical literature exists connecting these two things together, Gardasil and POTS. [00:08:40] Speaker 01: And, you know, this is, it's not the first case that the vaccine program is seen in this regard. [00:08:45] Speaker 01: And the special master is aware that medical literature exists. [00:08:49] Speaker 01: And the reason that they're cited is by their titles alone. [00:08:53] Speaker 01: they demonstrate that peer-reviewed medical literature is drawing a potential causal connection between Gardasil and these very complaints that are referenced in this young man's medical chart. [00:09:05] Speaker 03: Okay, this is Judge Chen. [00:09:07] Speaker 03: I just want to make sure I understand your thinking. [00:09:09] Speaker 03: Let's assume for the moment that we feel, just as we did in Cottingham, that we need to remand this back to the special master to consider the [00:09:23] Speaker 03: the Gardasil packaging which lists the symptoms that can occur from a vaccination. [00:09:31] Speaker 03: And then we also have to think about what are some of the other things that we want the special master to consider that maybe the special master didn't consider the first go around. [00:09:44] Speaker 03: I guess an additional item would be the VAERS form, is that right? [00:09:49] Speaker 03: Or the reference to VAERS, is that right? [00:09:53] Speaker 01: It would be, Your Honor. [00:09:54] Speaker 01: OK. [00:09:55] Speaker 03: And then, OK, let me keep going here. [00:09:57] Speaker 03: And so I just want to make sure I understand now your citations to medical literature, but not the actual inclusion into the record of copies of those articles. [00:10:13] Speaker 03: Are you saying that if you were to get a remand here, that on remand the special master would need to, [00:10:23] Speaker 03: get copies of those medical literature references and evaluate them in assessing the reasonable basis of the claim made? [00:10:34] Speaker 03: Or I'm just a little confused, given that they're technically not in the record, but there are citations to them. [00:10:43] Speaker 01: Yeah, right, Your Honor. [00:10:45] Speaker 03: What exactly it is you think? [00:10:47] Speaker 01: Yeah, so I will tell you, both VAERS [00:10:53] Speaker 01: report and the product monograph were both referenced to special master standards in briefing. [00:11:00] Speaker 01: I think there was a note in the government's red brief that this was not pointed out or suggested or highlighted to [00:11:12] Speaker 01: and that is not true. [00:11:14] Speaker 01: It's at page three of our original brief and page three of our reply in front of Special Master Sanders. [00:11:19] Speaker 01: So the argument about the VAERS report and the product monograph, you're absolutely right. [00:11:26] Speaker 01: Your Honor, those things should have been considered and formed the basis for reasonable basis, just as they did in Cottingham. [00:11:35] Speaker 00: The Journal of the Medical... Let me ask you a question. [00:11:38] Speaker 00: Articles, did you submit the articles to the Court of Federal Claims? [00:11:42] Speaker 01: No. [00:11:43] Speaker 00: Or cite them? [00:11:44] Speaker 00: So why do we have the same problem that Cottingham, that we saw in Cottingham, which is that these may be relevant, and it's possible the special master should have considered them, but there was nothing in the record. [00:12:02] Speaker 01: Right. [00:12:02] Speaker 01: That's what I was going to say, Your Honors. [00:12:04] Speaker 01: I mean, I don't think that [00:12:06] Speaker 01: Now, on remand, I think we would probably need to have a status conference with Special Master Sanders and, you know, discuss the medical literature. [00:12:18] Speaker 01: It's problematic because argument of counsel is, you know, not really evidence here, and it would be me arguing the weight and merit of medical journal articles, not an expert. [00:12:31] Speaker 00: So you're saying you would ask the... [00:12:34] Speaker 00: special master to reopen the record for purposes of considering those articles? [00:12:39] Speaker 01: I mean, I think so. [00:12:40] Speaker 01: I'm not really wanting to rely a ton on the journal articles before your honors because you're 100% correct in the sense that they were not in the record. [00:12:50] Speaker 01: As I said, they were cited to provide additional notice [00:12:55] Speaker 01: to special master standards that these complaints have been related in peer review journal articles. [00:13:00] Speaker 01: And as I said, I cited the one specifically that said pots after Gardasil, but they're not in the record. [00:13:08] Speaker 01: And I don't want to get in a situation before your honors where I'm trying to argue the import of [00:13:14] Speaker 01: information that is not in the record in front of the special master. [00:13:19] Speaker 01: But as this has developed, I think that they probably are relevant [00:13:28] Speaker 01: in the sense that if the special master wants to read them to, you know, confirm or corroborate that in fact those articles do draw a potential causal connection between vaccination and POTS, then I'd be more than willing to provide them to her. [00:13:47] Speaker 01: But, you know, we've got, we would basically have three lawyers trying to interpret [00:13:53] Speaker 01: medical literature without the guidance of an expert. [00:13:57] Speaker 01: I'm not sure how persuasive ultimately that becomes. [00:14:00] Speaker 02: Counsel, I think you may be close to out of your time, but I just need a short answer on this. [00:14:05] Speaker 02: This is Judge Raina. [00:14:06] Speaker 02: And this is with respect to the timing and severity of the symptoms. [00:14:11] Speaker 02: And so, and this is a challenge and re-challenge. [00:14:16] Speaker 02: Is the affidavit evidence on the timing and severity of the symptoms, are they objective evidence for the purposes of reasonable basis? [00:14:24] Speaker 02: If we look at that under the framework of challenge, re-challenge? [00:14:29] Speaker 01: You know, Your Honor, I think it is. [00:14:30] Speaker 01: I mean, it is under oath testimony, which certainly is evidence. [00:14:40] Speaker 01: Now, the timing and severity, as stated by the petitioner, is subjective in nature, no doubt. [00:14:49] Speaker 01: But under the totality of the circumstances test, [00:14:53] Speaker 01: I think what a special master should do is consider that evidence by itself. [00:15:00] Speaker 00: I don't even understand that statement, Counsel. [00:15:02] Speaker 00: How can you say it's subjective in nature when they're talking about the actual facts of what occurred and when it occurred and the level of occurrence? [00:15:16] Speaker 00: I could see it being subjective if you said, I think the vaccine caused this. [00:15:23] Speaker 00: or I don't think there's any other cause. [00:15:26] Speaker 00: But how is it subjective if one says this happened on this date? [00:15:31] Speaker 01: Well, yes, Your Honor. [00:15:33] Speaker 01: My point was, you know, any time a witness says, you know, I feel like these are, you know, vaccine related or I feel like this, I mean, that is in the affidavit. [00:15:49] Speaker 01: But when it becomes objective is when [00:15:52] Speaker 01: the victim or a parent testifies that something happened on a particular date and that is corroborated by the medical chart. [00:16:06] Speaker 01: I think that the special masters have to take under oath testimony like that into consideration under the totality of the circumstances. [00:16:17] Speaker 02: Why do you need corroboration? [00:16:19] Speaker 01: I don't understand that. [00:16:21] Speaker 01: No, I don't think you said. [00:16:25] Speaker 02: No, that is what I said, but on the point of corroboration, when you look at... So let me repeat my question in view of Judge O'Malley's question. [00:16:37] Speaker 02: I asked whether the evidence, the affidavit evidence that deals with the timing and the severity of the symptoms, whether that's objective evidence for purposes of reasonable basis. [00:16:49] Speaker 01: Okay. [00:16:50] Speaker 01: Then I took your question too far, I think. [00:16:53] Speaker 01: For purposes of what you just said, Your Honor, yes. [00:16:57] Speaker 01: I think it is objective evidence. [00:17:00] Speaker 01: Now, I took it a step further about this with Judge O'Malley's questions about, you know, I feel it. [00:17:05] Speaker 00: Counsel, you're way past your time, okay? [00:17:07] Speaker 00: Yes. [00:17:07] Speaker 00: Understood. [00:17:08] Speaker 00: Thank you. [00:17:08] Speaker 00: So we got your answer and it's yes. [00:17:09] Speaker 00: Okay. [00:17:11] Speaker 00: We'll hear from the other side. [00:17:15] Speaker 00: Ms. [00:17:15] Speaker 00: Collison? [00:17:17] Speaker 04: Good morning, and may it please the court. [00:17:23] Speaker 04: This case is distinct from the recently decided Cottingham matter in two important ways. [00:17:29] Speaker 04: First, here, the special master, in her opinion, reproduced it Appendix 75, determined that the evidence was insufficient to confer reasonable basis, not that there was no evidence, as was the case in Cottingham. [00:17:44] Speaker 04: and which was the basis for the court's finding that the special master there abused his discretion. [00:17:48] Speaker 04: Second, there was clear evidence of an alternate cause for petitioner's injuries, mononucleosis here, which the special master relied on when she weighed the evidence, and there was no such alternate cause in the record in Cottingham. [00:18:03] Speaker 00: But the special master in saying there wasn't enough evidence didn't consider a number of the factors that [00:18:12] Speaker 00: in Cottingham we said should have been considered. [00:18:16] Speaker 04: So I disagree with petitioners' counsel's argument on that point. [00:18:22] Speaker 04: The special master laid out her standard for assessing reasonable basis at Appendix Page 74, and then in applying that standard, she reviewed all the evidence that was presented to her through the petition and the fee petition, both of which are reproduced in the appendix in this case. [00:18:40] Speaker 04: And she determined within her discretion that the medical records were insufficient to show the claim's feasibility. [00:18:48] Speaker 04: So she considered all of the objective evidence as the set forth in the petition and fee petition. [00:18:55] Speaker 04: She summarized the fee petition's arguments in her opinion in Appendix Page 70. [00:19:00] Speaker 04: And then she summarized the objective evidence that she considered at Appendix Pages 71 to 73, which included, [00:19:08] Speaker 04: medical records that were specified in Petitioner C petition at Appendix 46. [00:19:14] Speaker 02: Counsel, this is Judge Arena. [00:19:19] Speaker 02: Let me ask you a question. [00:19:20] Speaker 02: We're dealing with the consistency of the objective evidence with the actual record. [00:19:27] Speaker 02: On Appendix 74, it says [00:19:31] Speaker 02: Right there at the beginning, that petitioner's argument that her submitted record provides objective evidence is inconsistent with the actual record. [00:19:39] Speaker 02: So then it goes on to show the inconsistencies, correct? [00:19:43] Speaker 02: And the first sentence says, petitioner had not received all medical records necessary to establish reasonable basis before she filed the petition. [00:19:50] Speaker 02: This is evidence by counsel's repeated attempts to collect additional records and discuss the program's burden approved prior to filing. [00:19:58] Speaker 02: Explain to me why that. [00:19:59] Speaker 02: That what I just read is not subjective evidence. [00:20:07] Speaker 04: Why that is not subjective? [00:20:09] Speaker 04: Oh, so subjective evidence that the special master would have been improper to consider. [00:20:16] Speaker 04: So it's not subjective evidence that was improper for her to consider first because [00:20:26] Speaker 02: She specifically stated that the... Our counsel's repeated attempts to obtain medical records. [00:20:37] Speaker 02: Is that subjective or is it objective evidence? [00:20:43] Speaker 04: His repeated attempts are not evidence at all. [00:20:47] Speaker 02: Right. [00:20:47] Speaker 02: We said that in Simmons, didn't we? [00:20:50] Speaker 02: We said that the conduct of the attorney is subjective evidence. [00:20:55] Speaker 02: Would you say then that the Special Master aired when they considered this timing and search for records and counsel's repeated attempts to collect additional records? [00:21:09] Speaker 04: I would not because what's important is that when he filed the case, he did not have evidence that a petitioner experienced [00:21:20] Speaker 04: relevant symptoms within a relevant time frame. [00:21:24] Speaker 02: No, that's not the question. [00:21:26] Speaker 02: The question is whether the attorney's conduct with respect to searching for records and acquiring records to bring the case, is that subjective evidence? [00:21:39] Speaker 02: It is, isn't it? [00:21:41] Speaker 04: Yes, and it goes to satisfying the attorney's good faith in bringing this claim. [00:21:44] Speaker 02: So, can I... Would it be fair for me to say that the special master erred when the special master could [00:21:51] Speaker 02: counterbalances, subjective evidence with the objective evidence that was submitted in the record? [00:21:58] Speaker 04: No. [00:21:59] Speaker 04: As this case, as this court set forth in Cottingham, what's required to show reasonable basis is more than a scintilla but less than a preponderance of objective proof. [00:22:11] Speaker 04: And the court specifically made clear that the weight of the objective evidence or whether that evidence establishes reasonable basis [00:22:18] Speaker 04: the factual finding for the special master. [00:22:21] Speaker 04: And that's what's important here. [00:22:23] Speaker 04: And in this case, unlike in Cottingham, the special master assessed the totality of the circumstances as she states in her conclusion. [00:22:33] Speaker 04: And her determination was that the level of objective evidence, just looking at objective evidence, was insufficient to show the claim's feasibility. [00:22:45] Speaker 04: Apparently... [00:22:47] Speaker 02: On the section that I just read and we're discussing right now, apparently the special master took that to be objective evidence. [00:23:00] Speaker 04: I don't understand how she did that and regardless, I mean, even if you took this paragraph out of the decision, the conclusion [00:23:11] Speaker 04: would still be the same. [00:23:12] Speaker 04: The special master made factual determination. [00:23:15] Speaker 02: How do we know? [00:23:16] Speaker 02: How do we know if in reaching the reasonable basis determination, the special master included in that consideration what is really subject to evidence? [00:23:29] Speaker 02: And we both have now agreed that attorney conduct is subject to evidence. [00:23:34] Speaker 02: So how do we know that the result would be the same? [00:23:40] Speaker 04: I would agree that an attorney's conduct is subjective evidence, but a lack of evidence, of subjective evidence or an understanding that there should be medical records to document what your clients are saying and an absence of that documentation, that is objective evidence. [00:24:09] Speaker 04: So I apologize if I misunderstood your Honor's question, but the lack of supporting documentation to support what is in the subjective affidavit, that is objective evidence that can be considered in a reasonable basis analysis. [00:24:30] Speaker 00: I have a question. [00:24:32] Speaker 00: Excuse me, Counsel, even if you think that this is a [00:24:37] Speaker 00: a different case than Cottingham. [00:24:40] Speaker 00: In light of the clear statements in Cottingham, why didn't the government just agree to a remand for purposes of reconsideration in light of the Cottingham decision? [00:24:54] Speaker 04: Well, first, I think, Your Honor, the Cottingham decision just came out fairly recently. [00:25:00] Speaker 04: We wanted to wait to hear this case until that decision came out. [00:25:06] Speaker 04: but we were not granted a continuing extension. [00:25:11] Speaker 04: But I do think that this case really is very different. [00:25:15] Speaker 04: I mean, the language that the special master used in. [00:25:18] Speaker 03: What about the package insert? [00:25:20] Speaker 03: I mean, the package says the list of symptoms, and we said in Cottingham, we have to send this back because the special master didn't consider that. [00:25:31] Speaker 03: And so why don't we just do that here? [00:25:34] Speaker 04: I can briefly address the package inserts, the medical literature, any of those items. [00:25:41] Speaker 04: The package insert in this particular case is not in the record. [00:25:45] Speaker 04: It was noted in Cottingham at flip-flop, page 13, footnote three, that no one contended it was not part of the record below. [00:25:53] Speaker 04: And here, I don't see it in the record below. [00:25:58] Speaker 04: It's not in the petition. [00:26:00] Speaker 04: It's not referenced in the petition. [00:26:02] Speaker 04: It's not in the appendix. [00:26:04] Speaker 03: Did you argue that in your red brief? [00:26:10] Speaker 04: I do think that I discussed the prescribing information at pages 17 to 19. [00:26:16] Speaker 04: I do think I stated that it's not in the records below. [00:26:20] Speaker 04: Even if it was filed below and would constitute some circumstantial objective evidence, I would argue to the special master who [00:26:32] Speaker 04: job it is to weigh the evidence in her discretion that the package insert here is certainly not persuasive for the reasons that I set forth in our brief. [00:26:43] Speaker 04: And that insufficiency, and that the reason that it's not persuasive is that... Well, that would be asking us to address it in the first instance, right? [00:26:54] Speaker 04: Correct. [00:26:55] Speaker 03: Okay. [00:26:56] Speaker 04: Correct. [00:26:57] Speaker 04: I think the point, if I may make, is that with prescribing information, medical literature, any kind of circumstantial objective evidence that's put in front of a special master, what we'd like guidance on is that there needs to be some kind of connection between that circumstantial evidence and the particular fact of a case. [00:27:21] Speaker 04: So, for example, in this case, the first episode... [00:27:26] Speaker 00: Fainting, the syncope, that's very much tied to this case, is it not? [00:27:35] Speaker 04: So the fainting in the prescribing information has nothing to do with the type of fainting that occurred in this case. [00:27:42] Speaker 04: And then the syncope discussed in the prescribing information is syncope related to the administration of the vaccine. [00:27:49] Speaker 04: So that's why you observe a patient for 15 minutes after the administration of a vaccine. [00:27:55] Speaker 04: Here, the syncope is, you know, arguably either related to an autonomic dysfunction, the special master in her discretion, you know, determines that the weight of the evidence suggested that's really probably more likely related to the mononucleosis diagnosis [00:28:13] Speaker 04: The same thing with headaches. [00:28:16] Speaker 04: You know, a headache can be a headache. [00:28:18] Speaker 04: It can be a sign of autonomic dysfunction. [00:28:22] Speaker 04: It can be just a headache. [00:28:24] Speaker 04: And here, in the adverse reaction section of the process. [00:28:28] Speaker 00: But I don't even understand. [00:28:29] Speaker 00: I mean, you're saying that you're making medical determinations on what you think the package insert was warning about. [00:28:44] Speaker 00: And so you think based on those determinations that it's not objective evidence? [00:28:51] Speaker 04: I'm not saying that it's not objective evidence. [00:28:54] Speaker 04: I'm saying that I would argue to a couple after weighing the evidence that it has very little persuasive value because there's not a connection to the specific facts in this case. [00:29:06] Speaker 04: That's my thing. [00:29:09] Speaker 04: And the same thing for medical literature. [00:29:12] Speaker 04: You know, here, as the petitioner acknowledged, medical literature was not filed. [00:29:18] Speaker 04: And as he also acknowledged, it's difficult for a special master to interpret medical literature without an expert opinion. [00:29:26] Speaker 00: Well, you don't have to fully interpret medical literature to know that you have met a very low standard of showing reasonable basis. [00:29:36] Speaker 00: I mean, we're talking basically just more than a scintilla of evidence. [00:29:41] Speaker 00: You don't have to determine that the medical literature was correct. [00:29:45] Speaker 00: You only have to determine that there was a reasonable basis because of all this medical literature existed to bring, to assert the claim. [00:29:54] Speaker 00: The vaccine acted. [00:29:58] Speaker 00: Right? [00:29:58] Speaker 00: I mean, you're not talking, we don't have to, they don't have to prove at this stage the merits of their claim. [00:30:08] Speaker 04: No, and I agree. [00:30:09] Speaker 04: But what they have to prove is that there's enough of a connection that warrants spending vaccine program funds to, you know, to address the petition. [00:30:19] Speaker 04: And very rarely do the special masters deny reasonable basis. [00:30:25] Speaker 04: And when they do so, they do so, you know, to make a point that there's not enough here, you're wasting my time. [00:30:32] Speaker 04: And the Vaccine Act does not intend for every single case to be compensated. [00:30:38] Speaker 04: And that's what we're trying to protect. [00:30:40] Speaker 04: And, you know, that is why the reasonable basis standard, I assume, is, you know, predicated on objective evidence similar to the preponderance standard is, you know, requires some, for the Act, Section 13A1, requires some substantiation by medical records or medical opinion. [00:31:06] Speaker 04: I mean, there has to be enough of a connection between, for a lay person to understand between a piece of evidence, objective evidence, like a medical article or their report and the particular facts of a case to rise to the level of satisfying reasonable basis. [00:31:28] Speaker 04: Otherwise, you know, every single case would be compensated, petition would be compensated in terms of fees. [00:31:35] Speaker 04: And that's not what the Act does. [00:31:38] Speaker 00: The Act does contemplate that it should be very much the exception when they're not compensated. [00:31:46] Speaker 00: And that's why they specifically don't require you to prevail on the merits in order to be compensated. [00:31:57] Speaker 04: Correct. [00:31:58] Speaker 04: And in this case, the special master [00:32:03] Speaker 04: you know, assessed a totality of the circumstances and determined that the claim was not feasible based on the objective evidence, that the objective evidence put forth was simply insufficient. [00:32:18] Speaker 04: She considered all of the objective evidence. [00:32:20] Speaker 02: Chancellor, that statement, the statement that you're making right now, that's the statement you made in your brief. [00:32:29] Speaker 02: That's kind of like your conclusion, and you're concluding now with that statement. [00:32:34] Speaker 02: But doesn't Cottingham change that statement? [00:32:37] Speaker 02: Aren't you, aren't you, are you unable to agree that Cottingham has an impact on this case? [00:32:46] Speaker 04: No, I very much agree that Cottingham has an impact on this case. [00:32:51] Speaker 02: Well, would the government then, now that you had a chance to look at it, would the government now agree to a remand? [00:32:58] Speaker 02: in order to consider this case in view of Cottingham? [00:33:05] Speaker 04: No, because in my reading of the special master's decision, this case, her decision actually comports with the central takeaways of Cottingham, which I drew to be first that reasonable basis can only be established with objective evidence, which is what the special master considered. [00:33:23] Speaker 04: Second, that all objective evidence presented to the special master at the time should be considered, which she did and more. [00:33:32] Speaker 02: And... So this is one of those cases where the special master says, not enough, you're wasting my time. [00:33:41] Speaker 02: Yes. [00:33:43] Speaker 04: Not that there was none, that there was not enough. [00:33:46] Speaker 04: Yes. [00:33:46] Speaker 00: Okay. [00:33:46] Speaker 00: Thank you. [00:33:47] Speaker 04: Thank you very much. [00:33:49] Speaker 00: Okay. [00:33:49] Speaker 00: Mr. Downing? [00:33:51] Speaker 00: Apologies, Your Honor. [00:33:52] Speaker 00: How much time should I set for rebuttal? [00:33:55] Speaker 00: Two minutes. [00:33:56] Speaker 00: Thank you. [00:34:06] Speaker 01: Your Honor, may I proceed? [00:34:09] Speaker 01: Yes. [00:34:11] Speaker 01: Okay, thank you. [00:34:12] Speaker 01: And just very briefly, to Judge Raines, your questions with regards to conduct of counsel [00:34:20] Speaker 01: I didn't have an opportunity to cover that in my opening. [00:34:23] Speaker 01: Obviously it's an issue in our briefing and I think it's important in the sense that obviously Simmons makes it clear that conduct of counsel is not objective evidence to satisfy the reasonable basis test and yet Special Master's standards devoted a lot of her analysis to going through my time sheets which is, you know, [00:34:45] Speaker 01: Judges aren't typically privy to those conversations with clients anyway, but in this instance, because of our system, they are. [00:34:52] Speaker 01: And then she spends a lot of time discussing counsel's conduct and speculating as to the fact that my conduct in meeting with my clients somehow reflects that the case lacked reasonable basis. [00:35:03] Speaker 01: I do think that's error. [00:35:05] Speaker 01: Again, I think this case is [00:35:09] Speaker 01: very, very similar to Cottingham. [00:35:13] Speaker 01: I appreciate the court's questions as to whether the government would agree to a remand because I think it's almost identical in the sense of what the special master did and failed to consider [00:35:26] Speaker 01: That evidence was in front of her at the time, cited to in the fee applications, laid out very clearly. [00:35:35] Speaker 01: But as I said earlier, I think this case is actually stronger than Cottingham, given the treating doctors' contemplation of reporting a vaccine adverse event to the CDC. [00:35:48] Speaker 03: That is really in the record. [00:35:52] Speaker 03: Yes, sir. [00:35:53] Speaker 03: Yes, sir. [00:35:54] Speaker 03: this morning from the other side that the package insert was not in front of the special master. [00:36:00] Speaker 03: Is that true or is that not true? [00:36:02] Speaker 01: Well, Your Honor, I mean, we presented that to special master standards exactly the same way council for the government presented it in their red brief at page 19. [00:36:14] Speaker 01: with a description of the symptoms associated with Gardasil and the clinical trials and the post-marketing experience and then citing to the product monograph. [00:36:26] Speaker 01: It's reproduced in the briefs and then given the site and at page 19 of the red brief, the site is exactly the same. [00:36:33] Speaker 01: It's referenced Merck's product insert for, you know, the particular Gardasil vaccine given. [00:36:40] Speaker 01: So, it wasn't from her. [00:36:44] Speaker 01: It's cited much in the same way as a case reference. [00:36:51] Speaker 01: So, but there's no statement in the red brief with regards to an objection that somehow that evidence was not in front of the special master at the time. [00:37:02] Speaker 00: Okay. [00:37:03] Speaker 00: Thank you, Counsel. [00:37:04] Speaker 00: The case will be submitted. [00:37:05] Speaker 00: Thank you, Your Honors. [00:37:07] Speaker 01: Thank you very much.